Identity
- Trade Name
- Fiber Optic Cable FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- The LightMat Surgical Illuminator product family are supplied as sterile or non-sterile, single use, latex free, plastic fiber optic devices intended to bring cool area lighting into deep surgical sites. The LightMat is typically attached to various surgical retractors though use of adhesive strips and/or pre-applied adhesive backing. Some models of the LightMat also contain internal malleable members to provide moderate blunt retraction on its own. FDA UDI
- Model / Reference
- 005776 FDA UDI
- Description
- The LightMat Surgical Illuminator product family are supplied as sterile or non-sterile, single use, latex free, plastic fiber optic devices intended to bring cool area lighting into deep surgical sites. The LightMat is typically attached to various surgical retractors though use of adhesive strips and/or pre-applied adhesive backing. Some models of the LightMat also contain internal malleable members to provide moderate blunt retraction on its own. FDA UDI
Identifiers
- Catalog Number
- 48250215 FDA UDI
- Primary DI / UDI-DI
- 00812432020569 FDA UDI
- FDA Product Code
- FDG FDA UDI
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4530 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Fiber Optic Cable by Lumitex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Lumitex, Inc.
Sources (1)
- FDA UDI 44e5763e-37b2-4aaa-8fe4-8f2d537a770a 35 fields · synced May 30, 2026